Articles

  • FDA wants to know more about St. Paul's firms plans for Zika Virus Test

    Published on March 9, 2016
    Authored by Mark DuVal
    Categorized as FDA News

    Mark DuVal is quoted in a Star Tribune article.

    Amid growing international demand for rapid Zika testing, the Food and Drug Administration wants to know more about a Minnesota company's plans to sell a service to test for the virus in human lab samples.

     

  • Off-Label Discussion Before and During Clinical Trials

    Published on February 3, 2016
    Authored by Mark DuVal
    Categorized as FDA News

    Off-Label Communications: A Guide to Sales & Marketing Compliance
    3. Off-Label Discussion Before and During Clinical Trials

    By Mark E. DuVal  and Bradley Merrill Thompson

    I. Introduction

    By this point, the book has provided excellent background on the legal underpinnings for off-label promotion and dissemination. The task now is to discuss off-label uses of products in the context of clinical trials. This helps the reader understand how clinical trials intersect with off-label promotion and other forms of communication. Thus the chapter begins with a conceptual layout of how one might view this world. What does a manufacturer confront when it markets a product that has utility well beyond its approved label? Remember, to discuss “off-label” uses implies that the product is already approved, has a label and there is potential for off-label uses of that product. Also, remember that off-label does not mean that the off-label use is inappropriate, nor is it necessarily dangerous. Rather, it means the product is deemed safe enough to be on the market, but it has not been studied for that particular unapproved use.

     

     

  • CMS's redrawn exemption for CME disallows sponsor choice of speaker

    Published on November 3, 2014
    Authored by Mark DuVal
    Categorized as FDA News

    Mark Gardner was quoted in a Medical Device Daily article written by Mark McCarty, Washington Editor, regarding 2015-2016 changes to the Sunshine Act.

    The Centers for Medicare & Medicaid Services released the Medicare physician fee schedule for calendar 2015 in a classic government data dump on Halloween, and among the items included in the MPFS is a revised exemption for sponsor payments made for continuing medical education. The final rule explains that when an applicable party funds a CME, but "does not either select or pay the covered recipient directly," that payment would be excluded so long as the sponsor did not provide the CME provider with "a distinct, identifiable set of covered recipients to be considered as speakers" at the event (Inside the Beltway).

    Read the full article here.

  • Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.

    Published on April 29, 2013
    Authored by Mark DuVal
    Categorized as FDA News

    Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.

    MDDI Device Talk Blog

    Posted: April 29, 2013

    Like the tributes thrust into the Hunger Games arena, medical device manufacturers want a fair shot at surviving the everchanging FDA 510(k) pathway.

    The FDA 510(k) program is beautiful and practical in its simplicity, and yet sophisticated in its ability to accommodate complexity and flexibility. It is as maligned as it is revered. But describing the nuanced process in detail is far too complex, as it requires an admixture of macro and micro politics, political philosophy being subtly carried out, and regulatory and administrative law, medicine, and science.
    By putting it into a caricature using the pop culture phenomenon The Hunger Games, however, I have tried to provide an amusing analogy to demonstrate what it’s like to take a client through the surprise-filled arena we call the 510(k) program as well as some tips on how to make it out alive.

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